Residual Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea (CRASH (French))

April 21, 2026 updated by: Hospices Civils de Lyon

Determinants of Residual Daytime Sleepiness and Accident Risk in Treated Obstructive Sleep Apnea: Impact of Baseline Hypoxic Burden and Evaluation of Alternatives to the Maintenance of Wakefulness Test

Obstructive sleep apnea (OSA) is a major cause of excessive daytime sleepiness and impaired vigilance, leading to an increased risk of road and occupational accidents. Despite effective treatment with continuous positive airway pressure (CPAP) or mandibular advancement devices, more than one third of treated patients report persistent subjective sleepiness and/or objective vigilance impairment.

The Maintenance of Wakefulness Test (MWT) is currently considered the legal reference test for the assessment of vigilance. However, its availability is limited and does not allow systematic and regular evaluation of all patients at risk.

This prospective study aims to identify determinants of residual daytime sleepiness and impaired vigilance in treated OSA, with a specific focus on the role of hypoxic burden at diagnosis. The study also aims to evaluate alternative behavioral and psychomotor tests as potential complementary tools to the MWT, and to assess their relationship with simulated driving performance and retrospective accident history.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Newly diagnosed moderate to severe obstructive sleep apnea, defined by an apnea-hypopnea index (AHI) ≥15 events/hour on diagnostic polysomnography.
  • Indication for obstructive sleep apnea treatment (continuous positive airway pressure, mandibular advancement device, positional therapy, or wake-promoting pharmacological treatment) as determined by the treating clinician.
  • Indication for Maintenance of Wakefulness Test due to reported sleepiness, declared or suspected accident risk, or professional driving or safety-related occupation.

Exclusion Criteria:

  • Previous treatment for obstructive sleep apnea.
  • Major cognitive impairment or language barrier preventing valid completion of vigilance tests or questionnaires.
  • Refusal or inability to undergo the Maintenance of Wakefulness Test.
  • Comorbid sleep disorders associated with hypersomnolence, including narcolepsy or idiopathic hypersomnia.
  • Pregnant or breastfeeding women.
  • Persons deprived of liberty by judicial or administrative decision, persons under legal protection (guardianship or curatorship), persons admitted to a health or social institution for reasons other than research, persons receiving compulsory psychiatric care, or persons not affiliated with a social security system or equivalent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated Obstructive Sleep Apnea Patients
Adult patients diagnosed with moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hour), treated with continuous positive airway pressure or mandibular advancement device, and referred for Maintenance of Wakefulness Testing as part of clinical care
Diagnostic test: Hypoxic burden computation, additional procedures and questionnaire

Polysomnographic data from diagnostic and treatment nights are collected to compute hypoxic burden and other sleep-related parameters.

Procedures performed as part of usual clinical care include the Maintenance of Wakefulness Test and routine clinical questionnaires assessing sleep, sleepiness, insomnia, mood, chronotype and anxiety, including the Karolinska Sleepiness Scale.

Additional procedures performed for research purposes include the Osler test, the Psychomotor Vigilance Task, a simulated driving test, and research-specific questionnaires, including a mind wandering scale and a retrospective questionnaire assessing road and occupational accident history.

No experimental treatment is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Hypoxic Burden According to Post-Treatment Vigilance Status
Time Frame: after a minimum of 28 days of treatment
Baseline hypoxic burden measured on diagnostic polysomnography, quantified as the cumulative depth and duration of oxygen desaturations associated with respiratory events. The primary analysis compares hypoxic burden between patients with impaired vigilance and those without impaired vigilance, defined by a mean sleep latency <33 minutes on the Maintenance of Wakefulness Test after treatment.
after a minimum of 28 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Baseline Hypoxic Burden and Mean Sleep Latency on the Maintenance of Wakefulness Test
Time Frame: After a minimum of 28 days of treatment.
Association between baseline hypoxic burden measured on diagnostic polysomnography and mean sleep latency (in minutes) obtained from the four Maintenance of Wakefulness Test trials performed after treatment.
After a minimum of 28 days of treatment.
Predictive Value of Baseline Polysomnographic and Psychobehavioral Markers for Maintenance of Wakefulness Test Results
Time Frame: After a minimum of 28 days of treatment.
Correlation between mean sleep latency on the Maintenance of Wakefulness Test and baseline polysomnographic parameters (apnea-hypopnea index, time with SpO₂ <90%, microarousal index, sleep efficiency, sleep stage distribution) and psychobehavioral measures collected at diagnosis and during vigilance assessment.
After a minimum of 28 days of treatment.
Performance on Alternative Vigilance Tests Compared With the Maintenance of Wakefulness Test And Association Between Vigilance Tests and Simulated Driving Performance
Time Frame: From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test
Correlation between Maintenance of Wakefulness Test results and alternative behavioral vigilance tests, including the Osler test (sleep latency) and the Psychomotor Vigilance Task (reaction time, lapses, false alarms). Sensitivity, specificity, positive predictive value, and negative predictive value of alternative tests are calculated using a mean sleep latency <33 minutes on the Maintenance of Wakefulness Test as the reference and relationship between Maintenance of Wakefulness Test results and simulated driving performance, assessed by inappropriate lane crossings and standard deviation of lateral position during a standardized driving simulation.
From hospital admission to hospital discharge, with alternative vigilance tests performed on the day preceding and the day of the Maintenance of Wakefulness Test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_1173

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on Hypoxic burden computation, additional procedures and questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe